ID

38974

Descripción

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Palabras clave

Versiones (1)
  1. 17/11/19 17/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de noviembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Inglés

Investigational Product (Dose)

1 formularios  
Day 8 AM Dose
Descripción

Day 8 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Investigational product container number
Descripción

Experimental drug, Container, Numbers

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 8 PM Dose
Descripción

Day 8 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 9 AM Dose
Descripción

Day 9 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 9 PM Dose
Descripción

Day 9 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Therapeutic procedure, Correct

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Day 10 AM Dose
Descripción

Day 10 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 10 PM Dose
Descripción

Day 10 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 11 AM Dose
Descripción

Day 11 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 11 PM Dose
Descripción

Day 11 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 12 AM Dose
Descripción

Day 12 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 12 PM Dose
Descripción

Day 12 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 13 AM Dose
Descripción

Day 13 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 13 PM Dose
Descripción

Day 13 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Therapeutic procedure, Correct

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Day 14 AM Dose
Descripción

Day 14 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Investigational product container number
Descripción

Experimental drug, Container, Numbers

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 14 PM Dose
Descripción

Day 14 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 15 AM Dose
Descripción

Day 15 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 15 PM Dose
Descripción

Day 15 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 16 AM Dose
Descripción

Day 16 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 16 PM Dose
Descripción

Day 16 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 17 AM Dose
Descripción

Day 17 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 17 PM Dose
Descripción

Day 17 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 18 AM Dose
Descripción

Day 18 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 18 PM Dose
Descripción

Day 18 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 19 AM Dose
Descripción

Day 19 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 19 PM Dose
Descripción

Day 19 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 20 AM Dose
Descripción

Day 20 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Descripción

Experimental drug, Dosage, Morning, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 20 PM Dose
Descripción

Day 20 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Therapeutic procedure, Correct

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
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Similar models

Investigational Product (Dose)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Day 8 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Experimental drug, Container, Numbers
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Day 8 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 9 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 9 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Day 10 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 10 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 11 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 11 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 12 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 12 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 13 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 13 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Day 14 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Experimental drug, Container, Numbers
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Day 14 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 15 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 15 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 16 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 16 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 17 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 17 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 18 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 18 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 19 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 19 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 20 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 20 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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